Ensuring full data integrity, without any exceptions23/05/2018 - Yves Dène, Lead Consultant CSV at Quality by Design
Data integrity is a cornerstone of scientific progress. However, a recent article in a leading Belgian newspaper shows that many researchers seem to tolerate violations against scientific integrity. As only accurate data will ensure safe and effective medication, it’s important that research-driven organisations put tools and processes in place to ensure data integrity.
The article in De Standaard doesn’t paint a pretty picture, to say the least. It highlights the outcome of the research doctorate of Simon Godecharle, who mapped the integrity of biomedical research in Belgium. Overall, 700 researchers participated in his survey, and the results were quite shocking.
Many participants admitted to have omitted data that didn’t fit in the picture. Furthermore, projects weren’t always managed as they should, while research results weren’t followed up appropriately.
Infringements in the grey zone
Just one look at the numbers suffices to start worrying. In the past 3 years, 70% of the questioned researchers at least committed 1 infringement upon research ethics. Over 90% of them claims to know colleagues who don’t work according to ethical standards.
This ‘grey zone’ of various violations against data integrity may even be a bigger problem than the conscious manipulation of data, as it is happening on a much larger scale. Moreover, there doesn’t seem to be a difference in this regard between academic professionals and researchers from the industry.
Clearly, the article raises a few questions. Why are there so many infringements nowadays? And, maybe more importantly, what can be done about them?
Various services to safeguard your data integrity
At QbD, we are convinced that trustworthy data are crucial to ensure safe and effective quality products. We see it as the foundation that guarantees trust between the industry and regulatory agencies.
Over the past years, we have assisted numerous companies in strongly regulated industries to ensure complete, consistent and accurate data. In the meantime, we have developed a wide range of services that help companies to ensure optimal data integrity. We enable our clients to attain full data integrity compliance, by adjusting our specialised methodologies to specific branches, businesses and products.
Next to this, we offer a one-day training on Good Laboratory Practices, helping you to gain crucial insights in compliance standards. Our half-day Design of Experiment training also helps you acquire important knowledge, which leads to improved process variation, performance aligned with planning, shorter development times, more reliability and reduced costs.
Discover how QbD helps to ensure data integrity in your organization.
Contact us today for more information on our data integrity services.